MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported the coil was placed outside of the target vessel.A 7mm x 20cm idc was selected for an arterial aneurysm embolization.Intermittent flush was used.The length was noted to be long for the lesion when trying to place.As the coil was retracted, it became detached within the non-bsc catheter.It was not noticed the coil had detached and another coil was inserted.Since the first coil remained in the catheter, it was pushed by the new coil and the complaint coil inside the catheter entered the body from the tip of the catheter.When the catheter was moved, it seemed that the coil was placed into the body.However, it was not in the aneurysm.The physician tried to retrieve the coil, but the snare could not be used with the 4fr system.The hub of the microcatheter was cut and it was changed to 6fr system.After that, the coil was retrieved by snare.There were no patient complications.
Event or Problem Description
It was reported the coil was placed outside of the target vessel.A 7mm x 20cm idc was selected for an arterial aneurysm embolization.Intermittent flush was used.The length was noted to be long for the lesion when trying to place.As the coil was retracted, it became detached within the non-bsc catheter.It was not noticed the coil had detached and another coil was inserted.Since the first coil remained in the catheter, it was pushed by the new coil and the complaint coil inside the catheter entered the body from the tip of the catheter.When the catheter was moved, it seemed that the coil was placed into the body.However, it was not in the aneurysm.The physician tried to retrieve the coil, but the snare could not be used with the 4fr system.The hub of the microcatheter was cut and it was changed to 6fr system.After that, the coil was retrieved by snare.There were no patient complications.It was further reported that the patient's condition was stable.It was corrected that this coil in mdr 2134265-2018-64525 was the second coil used in procedure of mdr 2134265-2018-64522.There were no issues with this second coil.As there was no issue or patient complication with this coil, this event no longer meets reporting criteria.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.It was corrected that there was no issue or patient complication with this coil, this event no longer meets reporting criteria.Updates were made to outcomes attrib to adv event, describe event or problem, device codes to clarify this.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8179164
• Report Number: 2134265-2018-64525
• Device Sequence Number: 1924169
• Product Code: KRD
• UDI-Device Identifier: 08714729158691
• UDI-Public: 08714729158691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0022614807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention